Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination.

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Gene Therapy Vaccination Vaccine Clinical Trials 304

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 18, 2022

The Union Ministry of Ayush is in the process of filling up nine posts created for setting up the office of Central Ayush Drugs Controller on a regular basis in consultation with the Union Public Service Commission (UPSC). It has recently appointed nine officers for additional charge in these posts without any additional remuneration, said […].

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NPR Health - Shots

DECEMBER 18, 2022

The CDC came out with two studies to detail the bivalent booster's effectiveness against COVID-related emergency department visits and hospitalization.

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BioSpace

DECEMBER 18, 2022

Q1 is the time when life science professionals are ramping up their job search efforts. If this applies to you, here are some tips to help you get a head start and prepare for your Q1 job search.

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Life Science 102

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

NPR Health - Shots

DECEMBER 18, 2022

Pope Francis has revealed in an interview published Sunday that shortly after being elected pontiff in 2013 he wrote a resignation letter in case medical problems impede him from doing his duties.

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pharmaphorum

DECEMBER 18, 2022

We live in unprecedented times, where innovation in biosciences continues to accelerate. Science has taken a vertical growth trajectory, yet such innovations are, at best, slow to reach the patients in need. We believe that innovation in patient access models is the necessary catalyst to aid patients in starting on and staying on the therapies they need to improve their lives.

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Branding Pharmacy Life Science Nurses 97

BioSpace

DECEMBER 18, 2022

Sanofi and Innate Pharma expand their longtime collaboration by licensing up to three NK cells engager programs in cancer immunotherapy valued at more than $1.4 billion.

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Licensing Licensing 85

Medical Xpress

DECEMBER 18, 2022

China's nursing homes are fighting an uphill battle to keep their elderly residents safe as a wave of COVID-19 infections sweeps the country following a relaxation of the government's zero-tolerance virus policy.

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Nurses 70

BioSpace

DECEMBER 18, 2022

Psychedelic and psychedelic-assisted therapies in the neuropsychiatric space have stalled for decades.

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Drug Patent Watch

DECEMBER 18, 2022

Annual Drug Patent Expirations for TOBI+PODHALER Tobi Podhaler is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There are…. The post New patent expiration for Mylan Speciality drug TOBI PODHALER appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

NPR Health - Shots

DECEMBER 18, 2022

NPR's Michel Martin speaks with Nick Miroff about his new series for The Washington Post focused on the opioid crisis and fentanyl.

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Drug Patent Watch

DECEMBER 18, 2022

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Branding Marketing 40

BioSpace

DECEMBER 18, 2022

Lilly digs deeper into metabolic diseases via GPCR partnership with Sosei.

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Clinical Trials Clinical Trials Vaccination Vaccine 40

Drug Patent Watch

DECEMBER 18, 2022

TOBI PODHALER (tobramycin) Mylan speciality lp Patent: 9,421,166 Expiration: Dec 19, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact…. The post Drug Patent Expirations for the Week of December 18, 2022 appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 40

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

FDA Law Blog

DECEMBER 18, 2022

By McKenzie E. Cato & Allyson B. Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction.

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Manufacturing Production Regulation 59

Drug Patent Watch

DECEMBER 18, 2022

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Branding Marketing 40

Drug Patent Watch

DECEMBER 18, 2022

This chart shows the pharmaceutical companies with the most liquid dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most liquid dosed drugs…. The post Which pharmaceutical companies have the most liquid dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 52